on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market

– having regard to the Commission proposal to Parliament and the Council (COM(2013)0288),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0141/2013),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 18 September 2013(1),

– having regard to Rules 55 of its Rules of Procedure,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0354/2013),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3. Instructs its President to forward its position to the Council and the Commission.

Amendment 1

Proposal for a regulation

Recital -1 (new)

Text proposed by the Commission

Amendment

(-1) Article 2 of Regulation (EU) No 528/2012 sets out the scope of that Regulation, and, among other things, excludes from its application biocidal products used as processing aids. Article 2(5) should be amended to clarify beyond doubt that 'processing aids' means those defined in Regulation (EC) No 1831/2003 of the European Parliament1 and Regulation (EC) No 1333/2008 of the European Parliament and of the Council2.

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1 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

2Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

Amendment 2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

1. Article 19(4)(c) of Regulation (EU) No 528/2012 prohibits authorisation for making available for use by the general public of biocidal products meeting the criteria for being persistent, bioaccumulative and toxic ('PBT'), or very persistent and very bioaccumulative ('vPvB') in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC . However, whereas biocidal products are often mixtures and sometimes articles, those criteria apply only to substances. Article 19(4)(c) of Regulation (EU) No 528/2012 should therefore refer to biocidal products consisting of, containing or generating substances meeting those criteria.

1. Article 19(4)(c) of Regulation (EU) No 528/2012 prohibits authorisation for making available for use by the general public of biocidal products meeting the criteria for being persistent, bioaccumulative and toxic ('PBT'), or very persistent and very bioaccumulative ('vPvB') in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. However, whereas biocidal products are often mixtures and sometimes articles, those criteria apply only to substances. Article 19(4)(c) of Regulation (EU) No 528/2012 should therefore refer to biocidal products consisting of, containing or generating substances meeting those criteria. In order to ensure consistency between Regulation (EU) No 528/2012 and Regulation (EC) No 1272/2008, Article 19(4)(b) of Regulation (EU) No 528/2012 should also be amended to include specific target organ toxicity by single or repeated exposurecategory 1 as a classification criterion in order topreclude authorisation for the making available on the market of a biocidal product containing such substances for use by the general public.

Amendment 3

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1a) Article 3(1)(s) should be amended to allow biocidal products with less severe classification to be part of a family based on higher risk formulations if they have similar composition, exposure levels, and proven efficacy.

(See amendments on Article 3(1)(s) and 19(6) on the Biocidal Product Family.)

Amendment 4

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) Article 19(6) should be amended to allow biocidal products with less severe classification to be part of a family based on higher risk formulations if they have similar composition, exposure levels, and proven efficacy.

(See amendments on Article 3(1)(s) and 19(6) on the Biocidal Product Family.)

Amendment 5

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

3a. Article 34(4) of Regulation (EU) No 528/2012 should be amended to correct the cross reference to Article 30.

Amendment 6

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

(5a) Some technical corrections should be made to Article 54 of Regulation (EU) No 528/2012 in order to avoid duplication between Article 54(1) and (3) as regards the payment of the applicable fees under Article 80(1).

Amendment 7

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission

Amendment

(6a) Article 66(4) of Regulation (EU) No 528/2012 should be amended to correct the crossreference to Article 67.

Amendment 8

Proposal for a regulation

Recital 6 b (new)

Text proposed by the Commission

Amendment

(6b) In order to facilitate good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement and to make use of existing structures, the Agency should also be tasked to provide support and assistance to Member States with regard to control and enforcement activities, in particular through the Forum.

Justification

REACH has established the so-called "Forum" to coordinate enforcement activities amongst Member States with the support of the Agency and the Commission. The Forum should also be used to facilitate enforcement of the Biocidal Products Regulation.

Amendment 9

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) Article 94(1) of Regulation (EU) No 528/2012 only applies to treated articles already placed on the market, and will hence introduce an unintended ban on most new treated articles, lasting from 1 September 2013 until the approval of the last active substance contained in the articles. Its scope should therefore be extended to include new treated articles. Article 94(1) should also provide for a phasing-out period for treated articles for which no application for the approval of the active substance for the relevant product-type will be submitted by 1 September 2016. In the interest of simplification, Article 94(2) should be merged with Article 94(1).

(15) Article 94(1) of Regulation (EU) No 528/2012 only applies to treated articles already placed on the market, and will hence introduce an unintended ban on most new treated articles, lasting from 1 September 2013 until the approval of the last active substance contained in the articles. Its scope should therefore be extended to include new treated articles. Article 94(1) should also provide for a phasing-out period for treated articles for which no application for the approval of the active substance for the relevant product-type will be submitted by 1 September 2016. In the interest of simplification, Article 94(2) should be merged with Article 94(1). In order to avoid potential adverse effects on economic operators, provision should be made for those modifications to apply from 1 September 2013.

Amendment 10

Proposal for a regulation

Article 1 – point –1 (new)

Regulation (EU) No 528/2012

Article 2 – paragraph 5 – point b

Present text

Amendment

(-1) In Article 2(5), point (b) is replaced by the following:

(b) biocidal products when used as processing aids.

"(b) biocidal products when used as processing aids, as defined in Article 3(1)(v).";

Amendment 11

Proposal for a regulation

Article 1 – point -1a (new)

Regulation 528/2012/EU

Article 3 – paragraph 1 – point s

Present text

Amendment

(-1a) In Article 3(1), point (s) is replaced by the following:

(s) "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products;

(s) "biocidal product family" means a group of biocidal products having similar uses, and similar composition with specified variations which do not adversely affect the level of risk or significantly reduce the efficacy of the products, the active substances of which have the same specifications;

Justification

Regulation 528/2012/EU should allow biocidal products with less severe classification to be part of a family based on higher risk formulations if they have similar composition, exposure levels, and proven efficacy.

Amendment 12

Proposal for a regulation

Article 1 – point 1 – point a a (new)

Regulation (EU) No 528/2012

Article 19 – paragraph 4 – point b

Present text

Amendment

(aa) in paragraph 4, point (b) is replaced by the following:

(b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

"(b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

6. In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate).

"6. In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The risk assessment for the biocidal product family conducted according to the common principles set out in Annex VI shall be based on the composition(s) and use(s) with the highest risk level for human health and animals, and the environment respectively.For each product within the biocidal product family, the classification, hazard and precautionary statements shall be the sameas, or of a lower concern than, those of the worst-case composition(s) evaluated in the risk assessment, and the level of exposure shall be the same as or lower than the worst case use(s) evaluated in that assessment.

A biocidal product family shall be authorised only if all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph, are expected to comply with the conditions set out in paragraph 1.

A biocidal product family shall be authorised only if the permitted variationsin composition and the uses referred to in the first subparagraph can be easily identified in the application together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures, and ifall the biocidal products within the family are expected to comply with the conditions set out in paragraph 1."

Justification

Regulation 528/2012/EU should allow biocidal products with less severe classification to be part of a family based on higher risk formulations if they have similar composition, exposure levels, and proven efficacy.

Amendment 14

Proposal for a regulation

Article 1 – point 2 a (new)

Regulation (EU) No 528/2012

Article 34 – paragraph 4 – subparagraph 2

Present text

Amendment

(2a) in Article 34(4), the second subparagraph is replaced by the following:

Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30(3) and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.

"Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.";

Amendment 15

Proposal for a regulation

Article 1 – point 5 a (new)

Regulation (EU) No 528/2012

Article 54 – paragraph 1

Text proposed by the Commission

Amendment

(5a) in Article 54, paragraph 1 is replaced by the following:

Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence ("the applicant") shall submit an application to the Agencyand pay the applicable fees in accordance with Article 80(1).

"Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the Agency.";

Amendment 16

Proposal for a regulation

Article 1 – point 6 a (new)

Regulation (EU) No 528/2012

Article 66 – paragraph 4

Present text

Amendment

(6a) in Article 66 paragraph 4 is replaced by the following:

Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 67(3) shall not be made available, including a justification as to why the disclosure of the information could be harmful for their commercial interests or those of any other party concerned.

"Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 67(3) and (4) shall not be made available, including a justification as to why the disclosure of the information could be harmful for their commercial interests or those of any other party concerned.";

Amendment 17

Proposal for a regulation

Article 1 – point 8 a (new)

Regulation 528/2012/EU

Article 74 – paragraph 2

Present text

Amendment

(8a) Article 74(2) is amended as follows:

2. Articles 78 to 84, 89 and 90 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis taking into account the role of the Agency with respect to this Regulation.

2. Article 77(4), Articles 78 to 84, 86, 89 and 90 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis, taking into account the role of the Agency and the role of the Member States' authorities with respect to this Regulation.

Justification

The scope of the work of the Forum for enforcement established by the REACH Regulation should be extended to the Biocidal Product Regulation (BPR). This is required to facilitate the coordination of the enforcement of the BPR at national level, for example as regards the granting and withdrawal of national biocidal product authorisations. Given that the Forum is already established under REACH, and its mandate was already extended to the PIC Regulation which is also managed by ECHA, it appears logical to build on the existing capacity to allow greater synergies across ECHA and the Member States as regards the enforcement of these three regulations. Moreover, support for enforcement authorities from ECHA was requested by Member State Competent Authorities and the Commission to ensure that national enforcement authorities have access to the ECHA’s tools required for their purposes and facilitate the interaction with ECHA. Given that for most, if not all, Member States the responsible authorities are same which enforce REACH, it seems efficient and effective to enlarge the Forum's competence to the BPR so that also the ECHA inspection IT tool for REACH (RIPE) can be expanded for biocides data.

Amendment 18

Proposal for a regulation

Article 1 – point 8 b (new)

Regulation 528/2012/EU

Article 76 – paragraph 1 – point ka (new)

Text proposed by the Commission

Amendment

(8b) In Article 76(1), the following point is inserted:

"(ka) providing support and assistance to Member States with regard to control and enforcement activities, in particular through the Forum established pursuant to Art. 86 of Regulation (EC) No 1907/2006."

Justification

In order to facilitate good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement and to make use of existing structures, the Agency should also be tasked to provide support and assistance to Member States with regard to control and enforcement activities, in particular through the Forum.

Amendment 19

Proposal for a regulation

Article 1 – point 9 a (new)

<DocAmend2>Regulation 528/2012/EU

Article 78 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

(9a) In Article 78(2), the second subparagraph is replaced by the following:

Revenue of the Agency referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation. Revenue of the Agency referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006.

Revenue of the Agency referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation, unless it is for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenue of the Agency referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006, unless it is for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Any transfers under this paragraph shall be returned to source at the latest on 15 May of the following financial year.

Amendment 20

Proposal for a regulation

Article 1 – point 11 – point a

Regulation (EU) No 528/2012

Article 89 – paragraph 2

Text proposed by the Commission

Amendment

(11) Article 89 is amended as follows:

(11) Article 89 is amended as follows:

(a) in paragraph 2, the first subparagraph is replaced by the following:

(a) paragraph 2 is replaced by the following:

"2.By way of derogation from Article 17(1), Article 19(1) and Article 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making a given biocidal product available on the market until three years after the date of approval of the last of the active substances to be approved in that biocidal product. It may, according to its national rules, authorise the making available on the market in its territory only of a biocidal product containing only existing active substances which

"2.By way of derogation from Article 17(1), Article 19(1) and Article 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making available on the market or using a given biocidal product until three years after the date of approval of the last of the active substances to be approved in that biocidal product. It may, according to its national rules, authorise the making available on the market and use in its territory only of a biocidal product containing only existing active substances which:

have been or are being evaluated under Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC*, but which have not yet been approved for that product-type, or

(a) have been evaluated under Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC*, but which have not yet been approved for that product-type,

(b) are being evaluated under Commission Regulation (EC) No 1451/2007 but which have not yet been approved for that product type,or

a combination of such substances and active substances approved in accordance with this Regulation.

(c) a combination of such substances and active substances approved in accordance with this Regulation.

By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1, and its current system or practice of using biocidal products for up to 18 months after that decision.

Amendment 21

Proposal for a regulation

Article 1 – point 11 – point ba (new)

Regulation (EU) No 528/2012

Article 89 – paragraph 3 – subparagraph 2

Present text

Amendment

(ba) in paragraph 3, the second subparagraph is replaced by the following:

To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States’ competent authorities no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product-type.

"To that effect, those wishing to apply for the authorisationof biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisationno later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applicationsshall be submitted no later than the date of approval of the last active substance for that product-type.

Amendment 22

Proposal for a regulation

Article 1 – point 11 – point c

Regulation (EU) No 528/2012

Article 89 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

"4. Where a Member State's competent authority decides to reject the application for authorisation of a biocidal product submitted under paragraph 3, decides not to grant authorisation, or decides to impose conditions of the authorisation making it necessary to change a product, the following shall apply:

"4. Where a Member State's competent authority, or where relevant, the Commission, decides to reject the application submitted in accordance with paragraph 3 for authorisation of a biocidal product already being placed on the market, decides not to grant authorisation, or decides to impose conditions of the authorisation which would require a change to such a product, the following shall apply:

Amendment 23

Proposal for a regulation

Article 1 - point 12

Regulation (EU) No 528/2012

Article 93 – paragraph 2

Text proposed by the Commission

Amendment

(12) in Article 93(2), the first and second subparagraphs are replaced by the following:

(12) in Article 93, paragraph 2 is replaced by the following:

"By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market biocidal productsreferred to in paragraph 1 of this Article for which an application was submitted in accordance with paragraph 1 of this Article until the date of the decision granting the authorisation. In the case of a decision refusing to grant the authorisation, or imposing conditions on the authorisation making it necessary to change a product, the biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market 180 days after such a decision.

"By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market and using a biocidal productnot covered within the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013. The derogation applies until one of the following dates:

By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market biocidal products referred to in paragraph 1 of this Article for which an application was not submitted in accordance with paragraph 1 of this Article until 180 days after 1 September 2017."

a) where applications for approval of all the active substances which the product consists of, contains or generates are submitted for the relevant product type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4);

b) where an application is not submitted in accordance with point a) for one of the active substances, until 1 September 2017.";

Amendment 24

Proposal for a regulation

Article 1 - point 13

Regulation (EU) No 528/2012

Article 94

Text proposed by the Commission

Amendment

"Article 94

"Article 94

Transitional measures concerning treated articles

Transitional measures concerning treated articles

By way of derogation from Article 58(2), a treated article treated with or incorporating a biocidal product containing only active substances referred to in Article 89(2) or for which an application for approval for the relevant product type is submitted at the latest by 1 September 2016, or only a combination of such substances and active substances referred to in Article 58(2), may be placed on the market until either of the following dates:

By way of derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing only active substances referred to in Article 89(2) or for which an application for approval for the relevant product type is submitted at the latest by 1 September 2016, or only a combination of such substances and active substances included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use, or in Annex I, may be placed on the market until either of the following dates:

1. in the absence of a decision not to approve one of the active substances for the relevant use, until the date of approval for the relevant product type and use of the last active substance contained in the biocidal product,

2. in the case of a decision not to approve one of the active substances for the relevant use, until 180 days after such a decision.

(a) in the case of a decision not to approve one of the active substances for the relevant use, until 180 days after such a decision;

(b) in other cases, until the date of approval for the relevant product type and use of the last active substance to be approved and contained in the biocidal product.

By further way of derogation from Article 58(2), a treated article treated with or incorporating a biocidal product containing any other substance than those referred to in that Article or in paragraph 1 of this Article may be placed on the market until 1 March 2017.

By way of further derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing an active substance other than those referred to in paragraph 1 of this Article or those included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, may be placed on the market until 1 March 2017.

1. As of 1 September 2013, the Agency shall make publicly available and regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IVA or IIA to Directive 98/8/EC and, where relevant, IIIA thereto (hereinafter 'complete substance dossier') has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that Directive (hereinafter 'relevant substances'). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the Agency in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, as well as the date of inclusion of the substance in the list.

1. As of 1 September 2013, the Agency shall make publicly available and regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IVA or IIA to Directive 98/8/EC and, where relevant, IIIA thereto ('complete substance dossier') has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that Directive ('relevant substances'). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the Agency in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.

A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products, (hereinafter 'substance supplier') may at any time submit to the Agency either a complete substance dossier, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired.

A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products, ('substance supplier') or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance ('product supplier'), may at any time submit to the Agency either a dossier for that relevant substance, a letter of access to such a dossier, or a reference to such a dossier for which all data protection periods have expired.

Where, for a relevant substance, no substance supplier is included in the list referred to in the first subparagraph, a person established within the Union who manufactures a biocidal product consisting of, containing or generating that relevant substance or places it on the market (hereinafter 'product supplier), may submit that information.

The Agency shall inform the submitting supplier of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fee within 30 days. It shall inform the submitter accordingly.

The Agency shall inform the submitting supplier of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fee within 30 days. It shall inform the submitter accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and inform the submitter accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and inform the submitter accordingly.

2. As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance included in the list referred to in paragraph 1 shall not be made available on the market or used unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1.";

2. As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance included in the list referred to in paragraph 1 shall not be made available on the market or used unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product types to which the product belongs.";

Amendment 26

Proposal for a regulation

Article 1 point 13

Regulation 528/2012/EU

Article 95 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

(13) in Article 95 the following point is inserted:

7a. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (the 'relevant data'). Following the renewal of the approval of an active substance, the Agency shall remove from the list referred to in paragraph 1 any substance supplier or product supplier included therein who has not within 6 months from the renewal submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 or in an application in accordance with Article 13.

Amendment 27

Proposal for a regulation

Article 1 – point 15

Regulation (EU) No 528/2012

Annex I – Category 6

Text proposed by the Commission

Amendment

(15) in Annex I, the entry named Category 6 is replaced by the following:

(15) in Annex I, the entry named Category 6 is replaced by the following:

"Category 6 – Substances for which a complete substance dossier has been submitted";

"Category 6 – Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC ";

The Parliament and Council adopted on 22 May 2012 Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products. The Biocidal Products Regulation represented a significant and substantial revision of the existing legislation governing biocidal products through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment.

Since its adoption, the Commission has identified a number of technical errors and unintended consequences in the Regulation, particularly as regards the transitional provisions in Articles 94 and 95. It has therefore adopted this amending proposal in order to make the necessary corrections and clarifications as soon as possible given the application of the Regulation as of 1 September 2013.

In order to provide the necessary legal clarity and certainty to Member States, industry and the general public, your Rapporteur therefore supports the Commission proposal. Furthermore, given the substantial revision undertaken only two years previously, your Rapporteur does not support any re-opening of issues of political substance agreed during the negotiation of the original Regulation.

Your Rapporteur has been informed that the Commission and Member States have, on examining this amending proposal, identified a small number of further technical clarifications which should be made to the text. These concern a clarification on the meaning of "processing aids", consistency with the legislation on classification, labelling and packaging of substances and mixtures and various corrections to cross-references and improvements to the drafting of the text. Your Rapporteur can support these additional improvements to the text and so they appear as amendments in the enclosed draft report.

PROCEDURE

Title

Amendment of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products